FDA-approved drugs are provided in many different forms based on the type of active substance, the indication treated and the preferred route of administration. These forms include enteral formulations (e.g., tablets, capsules or pills), parenteral formulations (e.g., injectable formulations such as intravenous, subcutaneous, intramuscular and intraarticular), liquid formulations (e.g., elixirs), lyophilized formulations and topical formulations. A majority of the FDA-approved drugs are currently available in enteral form, as either a tablet or capsule.
The production of pharmaceutical drugs in pill form by hot melt extrusion is relatively uncommon. While the idea of dissolving drugs in polymers and using extrusion to produce a pill has been known for decades, only a handful of FDA-approved drugs are extruded. Recently, extrusion techniques have been investigated for preparing abuse deterrent formulations. For example, U.S. Pat. No. 7,776,314 (assigned to Grunenthal, GmbH) is directed to abuse deterrent dosage systems. These systems contain only viscosity increasing agents to protect against abuse and do not teach specific combinations of matrix agents and controlled release agents. U.S. Pat. No. 8,101,630 (assigned to Acura Pharmaceuticals, Inc.) is directed to extended release opioid abuse deterrent compositions. The compositions contain high molecular weight gel forming polymers. U.S. Pat. No. 8,337,888 (assigned to Purdue Pharma L.P.) is directed to a pharmaceutical formulation containing a gelling agent. The formulations teaching polyethylene oxide (PEO) based matrix agents are osmotic dosage forms comprising a bilayer core, a delivery layer and semipermeable wall. U.S. 2012/065220 (assigned to Grunenthal, GmbH) is directed to a tamper resistant dosage form having an anionic polymer. The dosage form requires the use of an ethylenically unsaturated monomer bearing an anionic functional group to improve the mechanical properties of the dosage form.